Cervical Ripening With the Double Balloon Device for 6 Hours Compared With 12 Hours

Not Applicable

• Conditions: Induction of Labor; Unfavorable Cervix
• Interventions: Device: cervical ripening device

• Registration Number: NCT03045939
• Lead Sponsor: Bnai Zion Medical Center

Brief Summary

This study will evaluate the insertion of double balloon device (DBD) for cervical ripening for 12 h vs 6 hours.

Detailed Description

This randomized controlled study is designed to:

1. To assess and compare the Bishop score when removing the DBD 12 hours' vs 6hours' after insertion.

2. To compare the efficacy (vaginal delivery rate and time to VD) in the two arm groups

200 women are expected to be randomized in to two arms. One will be randomized to DBD removal after 12 hours and the other to DBD removal after 6 hours.

Each patient will sign an informed consent.

The following screening will be completed: medical and gynecological history, general physical and gynecological examination, ultrasonography to exclude contraindication to vaginal delivery or insertion if the DBD and non stress test (NST) for baseline. Bishop score will be assessed.

After confirming eligibility for study, randomization into the following groups will take place.

Insertion of the DBD and removal 6 hours following its insertion. Insertion of the DBD and removal 12 hours following its insertion.

Study Timeline

• Study First Submitted: 2017-01-24
• Study First Submitted QC: 2017-02-04
• Study First Posted: 2017-02-08
• Study Start: 2017-03-01
• Primary Completion: 2019-02-01
• Status Verified: 2019-03
• Study Completion: 2019-03-01
• Last Update Submitted: 2019-03-03
• Last Update Posted: 2019-03-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

1. Parous patients 18 years of age or older.

2. Diagnosed to be parous pregnant women with an indication for induction of labour.

3. Having a Bishop score of 5 or less.

4. Diagnosed as having a singleton pregnancy in a vertex presentation, with intact membranes, and no significant regular uterine contraction at gestational age of 37 completed gestational weeks or more.

5. Willingness to comply with the protocol for the duration of the study.

6. Have signed the informed consent.

Exclusion Criteria

1. A non -vertex presentation
2. Placenta previa
3. Ruptured membranes
4. Documented labour
5. Foetal distress necessitating immediate intervention
6. Proven malignancy of the cervix
7. Active inflammatory or purulent condition of the lower genital tract
8. Twin pregnancy
9. Any other contraindication for vaginal delivery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
12 hours	cervical ripening device	This arm is the standard management that includes insertion of the DBD into the cervical canal according to manufacture guidelines, removal after 12 hours followed by artificial rupture of membranes and oxytocin infusion according to departments protocol. (a total of 10 units of oxytocin is infused, initiated with 10 cc/h, increased by 10cc every 20-30 min until 3-5 contractions are present, total of not more than 120 cc\\h)
6 hours	cervical ripening device	Removal of the DBD after 6 hours, followed by artificial rupture of membranes and oxytocin infusion according to departments protocol. (a total of 10 units of oxytocin is infused, initiated with 10 cc/h, increased by 10cc every 20-30 min until 3-5 contractions are present, total of not more than 120 cc\\h)

Primary Outcome Measures

Name	Time	Method
time from insertion of the DBD to delivery	minutes or hours from insertion to delivery, assessed up to an estimated total of 24 hours	the time from insertion of the DBD until delivery will be assessed for each patient from each arm by hours/minutes

Secondary Outcome Measures

Name	Time	Method
rate of vaginal delivery	1 year	calculation of the rate of vaginal delivery in each arm will be calculated by number of Vaginal deliveries in each arm and the percentage.
maternal and neonatal adverse events	1 year

Trial Locations

Locations (1)

Bnai Zion Mc; 🇮🇱 Haifa, Israel